Dr. Zhihao Qiu, Head of External Policy & Regulatory Advocacy APAC at Roche/Genentech, Confirmed to Speak at CMC China Pharma Globalization Forum 2026

Dr. Zhihao Qiu currently serves as the Head of External Policy and Regulatory Affairs for Roche Genentech in China. He previously served as the Director of the Biotechnology Manufacturing Branch within the Office of Pharmaceutical Quality Assessment at the FDA’s Center for Drug Evaluation and Research (CDER). In this role, he was responsible for the scientific review and quality assessment of manufacturing controls and facilities for Biologics License Applications (BLAs), as well as conducting pre-license/pre-approval inspections of biologics regulated by CDER. An expert in microbial control and sterility assurance evaluation in biotechnology manufacturing, Dr. Qiu possesses extensive experience with FDA regulatory requirements regarding manufacturing facility assessments and Good Manufacturing Practice (GMP) compliance activities. Prior to joining CDER, he served as a CMC Facility Reviewer/Inspector at the FDA’s Center for Biologics Evaluation and Research (CBER), Deputy Director of Toxicology at the Center for Devices and Radiological Health (CDRH), and Chief Quality Officer at Innovent Biologics (Suzhou). Dr. Qiu holds a Ph.D. in Biological Sciences from the University of Southern California.